Position Summary:

Are you a passionate Life sciences manufacturing leader in who’s eager to translate science into global health solutions? If you are a GMP manufacturing expert with extensive leadership experience as well as vaccine experience, learn more and apply below!

IAVI is seeking an Experienced Leader who has depth of expertise in all phases of manufacturing processes, including drug substance, drug product, and development of analytical control strategies.  The Head of Manufacturing is accountable for process design, leading internal and external partners to establish critical quality attributes of drug substance, drug product, qualifying raw materials throughout the R&D life-cycle. The Head of Manufacturing is a GMP expert, as well as a seasoned leader who drives strategic decisions impacting the scale-up and development of best-in-class vaccines and treatments.

Key Responsibilities:

• Accountable for product and process development, scientific and engineering quality, and ensures all product quality attributes are understood and controlled through manufacturing and analytical controls.
• Partners with leadership on cross-functional teams to deliver and maintain processes and controls that are timely, phase-appropriate, and compliant, to meet clinical and commercial supply needs.
• Understands and responds to business priorities and translates these into tactical objectives and work direction.
• Mitigates risks to production schedules and program deliverables when necessary and ensures an effective tech transfer/process.
• Develops and executes a plan for validating the manufacturing process for IAVI’s portfolio of programs, each at various stages of development.
• Work with functional expertise throughout IAVI to conduct risk assessments for critical processes and develop mitigations plans.
• Collaborate with internal and external partners to develop and validate plans for at-scale production and drive the execution of these plans.
• When required, define protocols for tech transfers and facilitate evaluation and processes to ensure successful design of production, ensuring GMPs are fully integrated.
• Work with internal stakeholders (e.g., Regulatory) to ensure validation strategies fit within IAVI and our funders strategy.
• Collaborate with project management to maintain a detailed timeline for the activities that must be completed – communicate to team when activities are at risk of causing delays to timeline.
• Manage manufacturing to support commercial production.
• Understand process and analytical requirements for the entire process.
• Communicate process requirements to facilities engineers fit for purpose design.
• Creatively apply experience to ensure process design specifications are met on time and with high quality standards.
• Manage contract manufacturing oversight activities, such as reviewing of pre-campaign documentation, batch records, deviations, and approving batch release documentation.

Requirements

Education and Work Experience:

• Advanced degree or PhD in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or related field is required.
• Minimum of 15 years’ experience in biopharmaceutical/pharmaceutical manufacturing environment, with a minimum of 5 years’ senior management experience.
• Experience in early and late-stage product development, ideally having successfully been involved with bringing a product(s) to licensure.

Qualifications and Skills:

• Prior vaccines manufacturing experience is required.
• In depth experience with technology transfer and process validation is required.
• Experience overseeing CMOs and partnering with these organizations to drive results is required.
• Ability to dissect a manufacturing issue, conduct root cause assessments, and design experiments to test hypotheses stemming from manufacturing observations.
• Strong ability to motivate, mentor, and connect with peers and team members.
• Experience with CRO oversight, ensuring compliance with relevant regulatory standards required.
• Experience successfully managing and utilizing project management tools
• Ability to work across teams and SMEs to integrate information into centralized plans.
• Curiosity and drive to quickly come up to speed; creativity to solve challenging problems.
• Strong interpersonal skills, with excellent written and verbal communication skills.
• Ability to travel domestically and internationally as needed.
• A mission-driven individual with high energy and high levels of perseverance; works towards both individual and team goals.